510(k) · Cleared
Recalled · Class II · 2014Maersk Medical Pureline Comfort Subcutaneous Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
P/L Biomedical · FPA Set, Administration, Intravascular
Cleared on Aug 26, 1997 after an 81-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 of the 23 devices in its family, counting itself, has a Class I recall. 22 later devices descend from it. It has been recalled 16 times.
- Decided
- Aug 26, 1997
- Review
- 81 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 16
- Predicates
- 1
22 later devices descend from it, 8 citing it directly. 1 of the 23 devices in this family, counting this one, has a Class I recall.
- This deviceK972135 Maersk Medical Pureline Comfort Subcutaneous Infusion SetP/L Biomedical · 1997
- Descendant · cites it directly · 14 of its ownK032854 Unomedical Monica Infusion SetUnomedical A/S · 2003 · Recalled
- Descendant · 2 generations on · 3 of its ownK173879 MiniMed Mio Advance infusion setUnomedical A/S · 2018
- Descendant · cites it directly · 3 of its ownK014062 Simplicity Easy Access Infusion SetSterling Medivations, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK061374 Intuition Infusion SetsUnomedical A/S · 2006
- Descendant · cites it directly · 2 of its ownK041545 Contact DetachUnomedical A/S · 2004 · Recalled
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K162812 Unomedical Comfort Subcutaneous Infusion Set…cites it directly · 2017
Most influential descendants
Showing 5 of 22 · See all- K032854Unomedical Monica Infusion SetUnomedical A/S · 2003 · cites it directly14descendants
- K173879MiniMed Mio Advance infusion setUnomedical A/S · 2018 · 2 generations on3descendants
- K014062Simplicity Easy Access Infusion SetSterling Medivations, Inc. · 2002 · cites it directly3descendants
- K061374Intuition Infusion SetsUnomedical A/S · 2006 · cites it directly2descendants
- K041545Contact DetachUnomedical A/S · 2004 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972135 | Maersk Medical Pureline Comfort Subcutaneous Infusion Set | P/L Biomedical | 1997 | — |
| +1 | K032854 | Unomedical Monica Infusion Set | Unomedical A/S | 2003 | 1 |
| +2 | K173879 | MiniMed Mio Advance infusion set | Unomedical A/S | 2018 | — |
| +1 | K014062 | Simplicity Easy Access Infusion Set | Sterling Medivations, Inc. | 2002 | — |
| +1 | K061374 | Intuition Infusion Sets | Unomedical A/S | 2006 | — |
| +1 | K041545 | Contact Detach | Unomedical A/S | 2004 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 1 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K950018 | FDA’s K950018 is Cambridge Heart CH 2000 Stress Test System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1996 |
What descends from it? (22)
See all 228 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032854 | Unomedical Monica Infusion Set | 2003 | 14 |
| K014062 | Simplicity Easy Access Infusion Set | 2002 | 3 |
| K061374 | Intuition Infusion Sets | 2006 | 2 |
| K041545 | Contact Detach | 2004 | 2 |
| K051264 | Comfort and Inset Subcutaneous Infusion Sets for Use with Abbott Infusion Pumps | 2005 | 1 |
| K162812 | Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous… Class I | 2017 | 0 |
| K032485 | Medtronic Minimed Countach Infusion Set, Model 313 | 2003 | 0 |
| K984561 | Subcutaneous Infusion Sets, MSR Model a & B | 1999 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 20, 2014 | Class II | Z-0885-2015 | Device Design | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on… |
| Nov 20, 2014 | Class II | Z-0887-2015 | Device Design | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on… |
| Nov 20, 2014 | Class II | Z-0884-2015 | Device Design | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on… |
| Nov 20, 2014 | Class II | Z-0888-2015 | Device Design | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on… |
| Nov 20, 2014 | Class II | Z-0891-2015 | Device Design | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on… |
| Nov 20, 2014 | Class II | Z-0883-2015 | Device Design | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on… |
| Nov 20, 2014 | Class II | Z-0886-2015 | Device Design | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on… |
| Nov 20, 2014 | Class II | Z-0889-2015 | Device Design | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on… |
| Nov 20, 2014 | Class II | Z-0890-2015 | Device Design | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on… |
| Nov 20, 2014 | Class II | Z-0892-2015 | Device Design | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on… |
| Nov 20, 2014 | Class II | Z-0893-2015 | Device Design | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on… |
| Nov 20, 2014 | Class II | Z-0894-2015 | Device Design | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on… |
| Nov 7, 2014 | Class II | Z-0359-2017 | Device Design | Tubing detachment |
| Nov 7, 2014 | Class II | Z-0357-2017 | Device Design | Tubing detachment |
| Nov 7, 2014 | Class II | Z-0358-2017 | Device Design | Tubing detachment |
| Nov 7, 2014 | Class II | Z-0355-2017 | Device Design | Tubing detachment |
The 5 latest of 16 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K162812Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical…Unomedical A/S · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- Of its descendants, K032854 (Unomedical A/S, 2003) has gone furthest, with 14 descendants of its own.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The Subcutaneous Infusion Sets with indwelling Catheters are indicated for the infusion and/or injection of fluids into the body below the surface of the skin.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972135 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972135: Maersk Medical Pureline Comfort Subcutaneous Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972135
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026